NCT02678130

Brief Summary

The purpose of this post-approval study is to demonstrate that the InterFuse T modular lumbar interbody device is at least equal in safety and efficacy to other (standard of care) TLIF devices.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for phase_4 low-back-pain

Timeline
Completed

Started Jan 2015

Longer than P75 for phase_4 low-back-pain

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 22, 2016

Completed
18 days until next milestone

First Posted

Study publicly available on registry

February 9, 2016

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

November 2, 2016

Status Verified

November 1, 2016

Enrollment Period

3.4 years

First QC Date

January 22, 2016

Last Update Submit

November 1, 2016

Conditions

Low Back Pain

Keywords

Intervertebral disc degenerationBone DiseaseMusculoskeletal diseaseSpinal disease

Outcome Measures

Primary Outcomes (1)

  • fusion rates

    Assessment of the fusion rates as demonstrated by radiographic evidence.

    12 months

Secondary Outcomes (4)

  • Visual Analog Scale (VAS)

    up to 12 months

  • Oswestry Disability Score (ODI)

    12 months

  • SF-36

    12 months

  • Maintenance of disk height

    12 months

Other Outcomes (2)

  • Length of hospital stay

    up to 2-4 weeks

  • Opioid use

    baseline, at 2-4 weeks, at 6 months and at 12 months

Study Arms (2)

InterFuse Group

ACTIVE COMPARATOR

Patients are randomized based on last digit (odd) of social security number to be treated with an InterFuse T device

Device: InterFuse T

Control Group: Standard of care TLIF

ACTIVE COMPARATOR

treated with a standard of care TLIF (Transforaminal Lumbar Interbody Fusion) device (e.g. Stryker's AVS Unilif)

Device: Standard of Care TLIF (Stryker AVS Unilif)

Interventions

InterFuse TDEVICE

Transforaminal Lumbar Interbody fusion (TLIF)

InterFuse Group
Standard of Care TLIF (Stryker AVS Unilif)DEVICE

Transforaminal Lumbar Interbody Fusion (TLIF)

Control Group: Standard of care TLIF

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • meets indications for an interbody fusion (determined by the study investigator)
  • Has documented conservative (non-operative ) treatment for at least 3 months
  • Has a VAS back pain of \> or = 60mm
  • Has an ODI \> or = 40%
  • at least 18 years of age and skeletally mature
  • Willing and able to comply with study requirements
  • Patient's condition is appropriate for surgery
  • Agreed to participate in study

You may not qualify if:

  • Has severe osteoporosis or osteopenia
  • Grade 3 or higher Spondylolisthesis
  • Diffuse multilevel neoplastic disease such that no adjacent normal segment exists for engagement or instrumentation
  • Body Mass Index (BMI) \> 40
  • Patient has active infection
  • Patient is pregnant or planning to become pregnant
  • Patient is mentally ill or has history of drug abuse
  • Patient has known allergy to Polyetheretherketone (PEEK), stainless steel or Tantalum
  • Patient is currently enrolled in an investigational spine study
  • Has rheumatoid arthritis, ankylosing spondylitis or other autoimmune disease
  • patient bhas symptomatic fibrous arachnoiditis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

RECRUITING

MeSH Terms

Conditions

Low Back PainIntervertebral Disc DegenerationBone DiseasesMusculoskeletal DiseasesSpinal Diseases

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Stephen P Kallhorn, MD

    Medical University of South Carolina

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeff Felt, MD

CONTACT

612-708-4838jfelt@vti-spine.com

Ben A. Wasscher, MBA

CONTACT

763-218-4311bwasscher@vti-spine.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2016

First Posted

February 9, 2016

Study Start

January 1, 2015

Primary Completion

June 1, 2018

Study Completion

January 1, 2019

Last Updated

November 2, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will share

It is anticipated that data will be presented at scientific meetings and that a manuscript will be produced on the study

Locations

US(1)